Method of treatment of seborrheic dermatitis

ABSTRACT

A method of treatment of seborrheic dermatitis includes the application, in the form of either a lotion or a cream, of a mixture including a therapeutically effective amount of ivermectin in water preferably in a concentration of about 750 micrograms per milliliter (mcg/ml), in the case of a lotion, and with a pharmaceutically acceptable carrier if used as a cream. Such a lotion or cream is applied nightly preferably for a period of seven days and then employed on a maintenance basis one to four times per month.

REFERENCE TO RELATED APPLICATION

This case is a continuation of application Ser. No. 09/605,747, U.S.Pat. No. 6,319,945 filed Jun. 29, 2000.

BACKGROUND OF THE INVENTION

Seborrheic dermatitis, also known as seborrheic eczema and seborrhea, isa chronic superficial inflammatory disease of the skin capable ofaffecting many parts of the body including the scalp, eyebrows,nasolabial creases, lips, ears, sternal area, axillae, submammary folds,umbilicus, groins, and gluteul crease. The disease is characterized bymany shapes, sizes, and surface textures and is often crust-like,yellowish, and accompanied by itching. This is also characterized byremission and exacerbation.

The etiology, pathogenesis and histology of seborrheic dermatitis isunresolved. However, it bears close clinical resemblance to psoriasisand many researchers are of the belief that both conditions share arelated etiology, notwithstanding that psoriasis is a broader and lessdefinable condition. Therein, psoriasis typically differentiates overseborrheic dermatitis in its absence of itching and its resistancetreatment by compounds, such as, selenium sulfide and zinc pyrithionewhich have been employed in the treatment of seborrheic conditions.

Some researchers attribute seborrheic dermatitis to a zinc deficiencywhile others consider its etiology to be microbial. Yet others believethat a hormonal influence exists since the condition does not appearbefore puberty. It has also been hypothesized that a specific fungus,i.e., a lipophiolic plemorphic the fungus is responsible for variousforms of seborrheic dermatitis. As such, the argument that yeast, acommon form of such fungus, is at least one cause of such dermatitis, isconsidered a persuasive one.

Prior art which reflects the view that seborrheic dermatitis is a zincdeficiency is reflected in U.S. Pat. No. 5,997,852 (1999) to Akiko, etal, entitled Remedy For Dermatitis, while the school that viewsseborrheic dermatitis as microbial in origin and, thereby, urgestreatment of the same with antibiotics, is reflected in U.S. Pat. No.4,965,935 (1986) to Rosenberg, et al entitled Topical Treatment OfPsoriasis With Imidazole Antibiotics. As such, Rosenberg, et al equatespathogenic psoriasis with pathogenic seborrheic dermatitis. In this viewof the condition, it is also common to employ polymycinB-hydrocortisone, i.e., a cortisone-medicated antibiotic, as a topicalliquid.

The instant invention derives from the school which views soborrheicdermatitis as essentially fungal and, as such, caused by organisms atthe largest end of the spectrum of microscopic organisms. That is,organisms larger than bacteria, but is still not visible to human eye.These include as yet undetected microorganisms, amenable or responsiveto treatment with topical ivermectin.

SUMMARY OF THE INVENTION

The present invention constitutes a method of treatment of seborrheicdermatitis consisting of the application, in the form of either a lotionor a cream, of a mixture comprising a therapeutically effective amountof ivermectin in water in a concentration of about 750 micrograms permilliliter (mcg/ml), in the case of a lotion, and with apharmaceutically acceptable carrier if used as a cream. Such a lotion orcream is applied nightly for a period of seven days and then employed ona maintenance basis one to four times per month.

It is accordingly an object of the invention to provide a curativetopical therapy for the treatment of seborrheic dermatitis.

It is another object to provide a safe and effective method for thetreatment of such dermatitis which will afford a substantially permanentrelief therefrom.

The above and yet other objects and advantages of the present inventionwill become apparent from the hereinafter set forth Detailed Descriptionof the Invention and claims appended herewith.

DETAILED DESCRIPTION OF THE INVENTION

The inventive topical use of ivermectin, which is a part of a largerchemical family known as avermectins, has historically been a product ofMerck & Co., Inc., Rahway, N.J.

It is known to one skilled in the art that ivermectin is one ofcompounds of avermectin family. In fact, ivermectin is also called 22,23-dihydroavermectin B₁ as shown in the Merck Index (Eleventh Edition,pages 825-826, see attached copy). Furthermore, the relationship betweenivermectin and avermectins is also indicated in the definition ofavermectins in the Merck Index (Eleventh Edition, pages 140-141). It hashistorically been employed in veterinary applications for the treatmentof endoparasitic conditions in animals. However, some medical papers,particularly from the third world and tropical regions, have suggestedthat the use of ivermectin in humans in the treatment of internal orendoparasatic conditions, such as myiasis and onchocerciasis. However,these conditions have no known pathogenic or histologic connection toseborrheic dermatitis or, for that matter, to any known form ofpsoriasis. Further, no publication known to the within inventor has eversuggested employment of topical ivermectin in the treatment of any formof dermatitis.

The instant invention entails the use of a therapeutically effectivequantity of ivermectin, generally available from Merck as a paste,which, when dissolved in water, is sufficient to form a lotion having aconcentration of at least 750 mcg per ml. Alternatively, a cream ofivermectin may be formed, this in combination with a pharmaceuticallyacceptable carrier such as propylene glycol, sodium lauryl sulfate,zanthan gum, or combinations thereof.

The lotion or cream is then applied on a daily basis for seven days and,thereafter, one to four times per month on the affected area to preventrecurrence of the condition.

With respect to mechanism of action, it is believed that the effect ofivermectin upon the skin relates principally to sebaceous glands whichexist in almost every follicule of the human skin, and are vulnerable toattack by fungii. Accordingly, therein the fungus theory as well as thehormonal dysfunction theory of seborrheic dermatitis is addressed. Also,due to the relaxation effect on the skin which has been demonstrated inthe application thereto of ivermectin, the theory of etiology relativeto emotional stress and associated increased perspiration as a cause ofseborrheic dermatitis, is also addressed. As such, the quieting anddesensitizing effect of ivermectin is believed to subdue the motorlability to thereby reduce capillary stress associated with thecondition.

Over a period of experimental testing of about seven years upon about100 patients in my practice in Ormond Beach, Fla., I found results ofthe above method to be both safe and remarkably effective in thetreatment of otherwise stubborn conditions of seborrheic dermatitis.Further, where the patients have followed the proper regime of use ofivermectin, I have seen no recurrence of the condition. Also, none ofthe side effects, such as allergic irritation or burning, associatedwith prior art medication, particularly, topical antibiotics haveappeared. Thereby, in my use of the above described ivemectin lotion andcream, I have not encountered any auto immune response from patients sotreated as, occasionally, has been case with the using antibiotics suchas erythromycin, tetracycline, and imidazoles such as ketanazole.Accordingly, I believe I have discovered an effective and almostuniversally safe method of the treatment of seborrheic dermatitis whichmay have additional value in the treatment of types of psoriasis havingan etiology common to seborrheic dermatitis.

While there has been shown and described the preferred embodiment of theinstant invention it is to be appreciated that the invention may beembodied otherwise than is herein specifically shown and described andthat, within said embodiment, certain changes may be made in the formand arrangement of the parts without departing from the underlying ideasor principles of this invention as set forth in the claims appendedherewith.

Having thus described my invention, what I claim as new, useful andnon-obvious and, accordingly, secure by Letters Patent of the UnitedStates is:
 1. A method of treating seborrheic dermatitis comprisingtopically applying a therapeutically effective amount of ivermectin toan affected area of a human patient.
 2. The method of claim 1, whereinsaid ivermectin is in a pharmaceutically acceptable carrier.
 3. Themethod of claim 2, wherein said ivermectin is in a concentration of noless than 750 mcg/ml.
 4. The method of claim 2, wherein saidpharmaceutically acceptable carrier comprises water, propylene glycol,sodium lauryl sulfate, xanthum gum, and combinations thereof.
 5. Themethod of claim 4, wherein said ivermectin in a pharmaceuticallyacceptable carrier is in a form of lotion or cream.
 6. The method ofclaim 1, wherein said topically applying a therapeutically effectiveamount of ivermectin to said affected area of said patient comprisingthe steps of: (a) topically applying said ivermectin daily for a periodof about seven days, and (b) topically applying said ivermectin one tofour times per month for a period of several months.